Ovarian CancerNCT07807683
Circulating Endothelial Cells (CECs) as Potential Predictive/Prognostic Biomarkers in Ovarian Cancer
An observational study of Ovarian Cancer, run by Centro di Riferimento Oncologico - Aviano.
Trial summary
Anti-angiogenic agents, such as Bevacizumab, have demonstrated survival benefits in ovarian cancer, particularly in patients at high risk of disease progression. However, these therapies are costly, associated with potential side effects, and may negatively impact quality of life, benefiting only specific patient… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2014to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy donors and consecutive ovarian cancer patients
Who may be able to join
- Healthy adults caucasian female
- Non-smoker
- Normal blood pressure values
- Normal complete blood count (CBC)
- Normal blood chemistry values
- Caucasian
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- Patients with confirmed histological diagnosis of ovarian carcinoma (all histotypes)
- Treatment-naive or with disease recurrence occurring more than 12 months after the start of therapy
- Normal systolic and diastolic blood pressure values, no cardiovascular comorbidities
- Written informed consent
Who cannot join
- Diabetes
- Hypertension
- Active infectious states or chronic inflammatory diseases
- Active or previous malignancies
- Pharmacological treatment completed less than 48 hours prior
- Statin treatment
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- Endometriosis
- Cardiovascular disease / Heart disease
- End of menstrual cycle less than 15 days prior
- Non-fasting subjects
- Obesity
- Hypercholesterolemia
- Active gastric or duodenal ulcer
- Positive serology for HIV, Hepatitis A, B, or C infection
About this study
Official title: Flow Cytometric Evaluation of the Role of Circulating Endothelial Cells (CECs) as Potential Predictive/Prognostic Biomarkers in Ovarian Cancer
Anti-angiogenic agents, such as Bevacizumab, have demonstrated survival benefits in ovarian cancer, particularly in patients at high risk of disease progression. However, these therapies are costly, associated with potential side effects, and may negatively impact quality of life, benefiting only specific patient subgroups. Therefore, identifying reliable, predictive, and prognostic biomarkers that can be seamlessly integrated into clinical practice is essential to optimize patient selection.
Circulating endothelial cells (CECs)-mature endothelial cells shed from vascular walls following blood vessel damage-represent a promising biomarker for monitoring vascular injury, treatment response, and disease recurrence. While flow cytometry offers a rapid, cost-effective, and standardized approach for CEC enumeration, methodological variability across laboratories has historically limited its clinical utility. To overcome this, this study utilizes a standardized flow cytometry protocol (developed by Beckton Dickinson and the SCENIC consortium) combining DNA staining with a dried, pre-titrated 5-antibody panel to ensure consistent and reproducible CEC quantification.
Read more
Additionally, emerging evidence suggests that specific microRNA (miRNA) expression profiles in primary tumor tissue and plasma reflect vascular damage and response to anti-angiogenic therapy.
This study aims to evaluate the predictive and prognostic role of CEC counts (at baseline and post-treatment) in ovarian cancer patients receiving standard chemotherapy with or without Bevacizumab. Furthermore, it seeks to explore the correlation between baseline CEC levels and the expression of selected miRNAs in plasma and primary tumors.
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Biomarkers, miR-484, Circulating Endothelial Cells, Bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy controls | |
| Benign gynecological conditions | Women with benign ovarian mass | |
| EOC | Women with Epithelial Ovarian Cancer (EOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of CEC assessment in patients with ovarian cancer and description of baseline CECs
Description of baseline CECs with descriptive statistics
Measured: 4 years
Secondary outcomes (7)
Evaluation of changes in CEC counts following therapy (with or without Bevacizumab) in patients with ovarian cancer
Fold change of CEC counts between different assessments: baseline, at the end of chemotherapy, at progression
Measured: 4 years
Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Progression-Free Survival (PFS)
Difference in PFS between subgroups of patients will be evaluated with log-rank test
Measured: 4 years
Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Overall Survival (OS)
Difference in OS between subgroups of patients will be evaluated with log-rank test
Measured: 8 years
Evaluation of changes in selected microRNA (miR) level following therapy (with or without Bevacizumab) in patients with ovarian cancer
Fold change of selected microRNA level between different assessments: baseline, at the end of chemotherapy, at progression
Measured: 4 years
Assessment of the prognostic role of changes in selected microRNA levels over time in patients with ovarian cancer in terms of PFS and OS
Difference in PFS between subgroups of patients will be evaluated with Kaplan-Meier method and log-rank test
Measured: 4 years
Assessment of the prognostic role of selected microRNA in patients with ovarian cancer in terms of PFS and OS
Difference in OS between subgroups of patients with different microRNA level will be evaluated with Kaplan-Meier method and log-rank test. OS will be defined as time from the beginning of second line platinum based therapy and death or end of follow-up whichever comes first
Measured: 8 years
Correlation between CEC counts at diagnosis and expression of selected microRNA in serum and primary tumors
correlation between CEC baseline counts and selected microRNA level
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustavo Baldassarre, Principal investigator, Centro di Riferimento Oncologico di Aviano - IRCCS CROFrancesca Rossi, Principal investigator, Centro di Riferimento Oncologico di Aviano - IRCCS CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807683
- Sponsor's protocol ID
- CEC_2014
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometric Evaluation of the Role of Circulating Endothelial Cells (CECs) as Potential Predictive/Prognostic Biomarkers in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07807683
- Acronym / sponsor ID
- CEC_2014
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Biomarkers, miR-484, Circulating Endothelial Cells, Bevacizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 15 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anti-angiogenic agents, such as Bevacizumab, have demonstrated survival benefits in ovarian cancer, particularly in patients at high risk of disease progression. However, these therapies are costly, associated with potential side effects, and may negatively impact quality of life, benefiting only specific patient subgroups. Therefore, identifying reliable, predictive, and prognostic biomarkers that can be seamlessly integrated into clinical practice is essential to optimize patient selection.
Circulating endothelial cells (CECs)-mature endothelial cells shed from vascular walls following blood vessel damage-represent a promising biomarker for monitoring vascular injury, treatment response, and disease recurrence. While flow cytometry offers a rapid, cost-effective, and standardized approach for CEC enumeration, methodological variability across laboratories has historically limited its clinical utility. To overcome this, this study utilizes a standardized flow cytometry protocol (developed by Beckton Dickinson and the SCENIC consortium) combining DNA staining with a dried, pre-titrated 5-antibody panel to ensure consistent and reproducible CEC quantification.
Additionally, emerging evidence suggests that specific microRNA (miRNA) expression profiles in primary tumor tissue and plasma reflect vascular damage and response to anti-angiogenic therapy.
This study aims to evaluate the predictive and prognostic role of CEC counts (at baseline and post-treatment) in ovarian cancer patients receiving standard chemotherapy with or without Bevacizumab. Furthermore, it seeks to explore the correlation between baseline CEC levels and the expression of selected miRNAs in plasma and primary tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy controls |
| Benign gynecological conditions | – | –Women with benign ovarian mass |
| EOC | – | –Women with Epithelial Ovarian Cancer (EOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy donors and consecutive ovarian cancer patients
Key inclusion criteria (10 listed)
- Healthy adults caucasian female
- Non-smoker
- Normal blood pressure values
- Normal complete blood count (CBC)
- Normal blood chemistry values
Key exclusion criteria (14 listed)
- Diabetes
- Hypertension
- Active infectious states or chronic inflammatory diseases
- Active or previous malignancies
- Pharmacological treatment completed less than 48 hours prior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optimization of CEC assessment in patients with ovarian cancer and description of baseline CECs
Time frame: 4 years
Description of baseline CECs with descriptive statistics
7 secondary outcomes
Evaluation of changes in CEC counts following therapy (with or without Bevacizumab) in patients with ovarian cancer
Time frame: 4 years
Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Progression-Free Survival (PFS)
Time frame: 4 years
Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Overall Survival (OS)
Time frame: 8 years
Evaluation of changes in selected microRNA (miR) level following therapy (with or without Bevacizumab) in patients with ovarian cancer
Time frame: 4 years
Assessment of the prognostic role of changes in selected microRNA levels over time in patients with ovarian cancer in terms of PFS and OS
Time frame: 4 years
Assessment of the prognostic role of selected microRNA in patients with ovarian cancer in terms of PFS and OS
Time frame: 8 years
Correlation between CEC counts at diagnosis and expression of selected microRNA in serum and primary tumors
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Baldassarre principal investigator
Centro di Riferimento Oncologico di Aviano - IRCCS CRO
Francesca Rossi principal investigator
Centro di Riferimento Oncologico di Aviano - IRCCS CRO
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Centro di Riferimento Oncologico - Aviano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization of CEC assessment in patients with ovarian cancer and description of baseline CECs (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.